FDA Approves Actemra for Cytokine Release Syndrome

    cytokine release syndrome

    In August, the U.S. Food and Drug Administration (FDA) approved Actemra to treat CAR T cell-induced cytokine release syndrome (CRS). CRS is a rare, yet life-threatening side effect of a targeted immunotherapy treatment for certain serious cancers. The FDA hopes Actemra (a biological therapy rheumatoid arthritis drug) can help patients quickly clear their Car T cell-induced CRS. But professionals also worry about additional side effects this arthritis drug may cause after treatment. And issues with the two clinical trial groups given Actemra for cytokine release syndrome worry researchers as well as physicians.

    What Causes Cancer Patients to Develop Cytokine Release Syndrome?

    CAR T cell therapies are breakout treatments that modify a patient’s own white blood cells to specifically target cancerous cells. It involves removing the patient’s own T cells by leukapheresis, and transporting them to Novartis’s laboratory in New Jersey. From there, the T cells are genetically altered to produce chimeric antigen receptors (CAR) on their surface and multiplied. After completing a lympodepleting chemotherapy regimen, these CAR T cells are then reinfused back into the patient. This process allows the patient’s own T cells to target and kill specific cancer cells that contain B-cell antigen CD19.

    While this breakthrough therapy is exciting, it can also trigger an overactive immune response known as cytokine release syndrome (CRS). CRS is a rare, but also potentially deadly CAR T cell therapy side effect. Most people who develop CRS experience mild or moderate flu-like symptoms. The FDA approved Actemra to treat CRS because it’s an interleukin-6 inhibitor that changes the way your immune system works. While this makes Actemra (tocilizumab) effective for specific patient populations, it also makes you more likely to develop serious infections. Other life-threatening Actemra complications reported by study subjects include cardiac dysfunction, acute respiratory distress syndrome or multi-organ failure.

    Problems Affecting the Actemra Clinical Trial Group

    The FDA based their approval on a retrospective pooled data analysis from recent CAR T cell therapy clinical trials. The trials assessed Actemra’s efficacy when treating severe CRS in 45 pediatric and adult patients. Thirty-one patients achieved a responsive CRS resolution within 14 days after their first Actemra infusion. But this phase 2 study group included just 63 patients total — and only 52 received either Actemra or RoActemra infusions. This small CRS subject group makes some medical experts wonder how effective this treatment will be for larger patient populations.

    Forbes reports the cost for consumers given this new FDA-approved Actemra treatment for Car T Cell-induced CRS is quite expensive. According to a conference call with Swiss drug manufacturer Novartis, the company said its new treatment charged $475,000 per patient. The prohibitively expensive price tag combined with Actemra’s potentially dangerous side effects only complicate the FDA’s newly approved treatment application. (Especially for pediatric cases, since Actemra is only approved for use in patients aged two and older.)

    Actemra’s Drug Label Lists Some, But Not All Possible Health Complications

    STAT News recently published a rheumatoid arthritis drug review analyzing more than 500,000 side-effect reports in the FDA’s FAERS system. They found that Actemra’s serious side effect risks were as high or even higher than with other competing RA medications. Some life-threatening Actemra complications may include:

    • Heart attack
    • Stroke
    • Heart failure
    • Interstitial lung disease

    While most rheumatoid arthritis drugs like Humira, Enbrel and Remicade include warning labels listing these health risks, Actemra does not. As a result, thousands of people already suffered life-threatening effects, including 1,128 who died shortly after taking Actemra.

    What Actemra Victims Can Do

    If you or someone you love experienced Actemra-induced health problems, let us help you get the justice you deserve. To see if you may qualify for a cash settlement from the manufacturer, fill out your Actemra compensation evaluation now. Once you’ve submitted your information, an advocate who’s familiar with this issue will contact you to discuss your compensation options.

    Related: Temporal Arteritis Study: Actemra Works 3x Better Than Corticosteroids

    Mandy Voisin

    Mandy Voisin is a freelance writer, blogger, and author of Girls of the Ocean and Star of Deliverance. As an accomplished content marketing consultant, mom of four and doctor's wife, Mandy has written hundreds of articles about dangerous drugs and medical devices, medical issues that impact disabled Americans, veterans' healthcare and workers' compensation issues since 2016.

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